Stihler PRISMAFLO II Blood Return Warmer Recalled for Burn Risk
Stihler Electronic Gmbh is recalling PRISMAFLO II blood return warmers because damage to the heating profile may cause low-level skin burns.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (skin burns) where specific injury counts are not reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Stihler Electronic Gmbh is recalling 247 units of the PRISMAFLO II Heating Profile, a blood return warmer used with the Prismaflex system. The recall is limited to the heating profile component and does not include the control unit. The affected units have serial numbers ranging from UH07154 to UH07479 and were distributed worldwide, including in California and Switzerland.
The recall is being issued because damage to the heating profile may result in a hotspot, which may cause low-level skin burns. The product is used for warming return blood flow.
Consumers and healthcare facilities should stop using the affected heating profiles and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product Code: PF2-WP2618 Product Usage: The PRISMAFLO IIS warmer is used for warming return blood flow.
- Manufacturer
- Stihler Electronic Gmbh
- Category
- Medical Device — Blood Warmer
- Hazard
- Affected units
- 247
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial Numbers: UH07154 to UH07479
Distribution
Part of a larger recall action
This product is one of 3 recalled by Stihler Electronic Gmbh under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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